FDA 483 - Eone Laboratories - August 30, 2023

An FDA inspection of Eone Laboratories, a testing laboratory in Incheon, Korea, revealed a significant repeat observation regarding inadequate record-keeping for microbiology testing of HCT/P products. The firm failed to maintain detailed records providing a complete history of work performed, specifically concerning microbiology worksheets, sample readings, and secondary reviews. This repeated finding indicates a persistent issue with documentation practices at the facility.